What We Do

What We Do

What We Do

What We Do

Pharmatech Associates is a full service, global consultancy. We help manufacturers bring quality medicines to patients.

There are always moments of uncertainty regarding the likelihood that a new medicine or medical device will progress to the next phase. Our proprietary ecosystem helps to streamline the process through four integrated product development areas: Compliance. Product and Process Development. Regulatory Affairs. Facilities and Capital Projects, including Validation. Each area is further supported by leading experts with deep experience across the entire drug and device development lifecycle.

Pharmatech Associates is a full service, global consultancy. We help manufacturers bring quality medicines to patients.

There are always moments of uncertainty regarding the likelihood that a new medicine or medical device will progress to the next phase. Our proprietary ecosystem helps to streamline the process through four integrated product development areas: Compliance. Product and Process Development. Regulatory Affairs. Facilities and Capital Projects, including Validation. Each area is further supported by leading experts with deep experience across the entire drug and device development lifecycle.

Value in Our Process

The Pharmatech ecosystem comprises four foundational knowledge areas of product development: Compliance, Product and Process Development, Regulatory Affairs, and Facilities and Capital Projects including Validation. Our subject matter experts (SMEs) have fully integrated knowledge across the drug and device development lifecycle. This translates to more informed decision making, smaller, nimbler teams, and reduced program risk. We provide support to our clients from design through commercial implementation.

Value in Our Process

Value in Our Process

The Pharmatech ecosystem comprises four foundational knowledge areas of product development: Compliance, Product and Process Development, Regulatory Affairs, and Facilities and Capital Projects including Validation. Our subject matter experts (SMEs) have fully integrated knowledge across the drug and device development lifecycle. This translates to more informed decision making, smaller, nimbler teams, and reduced program risk. We provide support to our clients from design through commercial implementation.

Product & Process Development

Bringing a medical product to market is a complex undertaking. The product development processes require a proven, systematic approach that balances product quality, regulatory risk and stakeholder demands to minimize time to market.

Regulatory

We offer strategic guidance to help build a Quality Management System focused on efficient processes that support regulatory activities, updates, and filings.

Facilities & Capital Projects

Using risk-based tools, timelines are condensed to make the most of your budget and minimize compliance risks. Our agile validation services are designed to evolve as regulatory, scientific, or business conditions change.

Compliance

Our priority is to minimize compliance risks for your entire product life cycle while establishing customized building blocks for scalability.

Solutions
Product & Process Development
Regulatory
Facilities & Capital Projects
Compliance
Over-the-Horizon Capabilities

Over-the-Horizon Capabilities

Over-the-Horizon Capabilities

Over-the-Horizon Capabilities

Throughout the product development lifecycle, the unknowns often outnumber the knowns. An experienced advisor who anticipates the challenges that lie beyond the horizon – and provides trusted insight to address them – infuses your entire process with a strategy that’s proactive. By starting with the end goal in mind, we partner with you to develop a clear roadmap that guides you from innovation to execution.

Throughout the product development lifecycle, the unknowns often outnumber the knowns. An experienced advisor who anticipates the challenges that lie beyond the horizon – and provides trusted insight to address them – infuses your entire process with a strategy that’s proactive. By starting with the end goal in mind, we partner with you to develop a clear roadmap that guides you from innovation to execution.

How We Can Help

Regulatory

Regulatory

We anticipate and integrate the commercial impact of regulatory challenges and questions into a proactive strategy. We negotiate on your behalf by presenting alternative solutions. The result? More efficient regulatory interactions and shorter review timelines.

Compliance

Compliance

Modern therapies challenge traditional quality management practices. We harness the power of operational excellence to architect agile quality management systems responsive to evolving compliance requirements.

Facilities & Capital Projects

Facilities & Capital Projects

Building on a strong background in facility start-up and operations, we help you optimize the true cost of ownership from construction to full operation. Our expertise is vast – from small molecule and medical device projects to biologics, combination products, and cell/gene therapies.

Product & Process Development

Product & Process Development

Effective product development lays the foundation for a smoother regulatory process down the development lifecycle. By anticipating regulatory agency concerns, we efficiently and effectively move a drug program through development with little to no re-work.

Tailored Outcomes

Tailored Outcomes

Tailored Outcomes

Tailored Outcomes

Start-ups. Big Pharma. Biotech. Each must go through the same phases of development for their intended market. Each have unique capabilities, initiatives and success metrics. Our end-to-end expertise allows for pragmatic solutions tailored to your company’s maturity, all while meeting the needs of regulatory authorities around the world. Our system solutions are designed to scale as your organization and business processes evolve.

Start-ups. Big Pharma. Biotech. Each must go through the same phases of development for their intended market. Each have unique capabilities, initiatives and success metrics. Our end-to-end expertise allows for pragmatic solutions tailored to your company’s maturity, all while meeting the needs of regulatory authorities around the world. Our system solutions are designed to scale as your organization and business processes evolve.

How We Can Help

Regulatory

Regulatory

We develop a tailored regulatory strategy that defines CMC, non-clinical and clinical requirements based on your intended claims and target markets. We maximize the utility of the work that’s been done, regardless of where you are in your development journey.

Compliance

Compliance

As late-stage clinical and regulatory submission nears, we proactively develop a tailored Quality Management System that evolves with the maturity of your organization and its business strategy, executed as the role of quality becomes increasingly important throughout the process.

Facilities & Capital Projects

Facilities & Capital Projects

Our focus is on creating efficient and effective facilities that make the most of your current budget, resources, and goals. As your business grows, you can be sure that scalability is built-in.

Product & Process Development

Product & Process Development

We provide turnkey solutions, supporting your tailored product and process development efforts from CMC characterization strategy to final commercialization.

Success the First Time

Success the First Time

Success the First Time

Success the First Time

The drug and medical device development process often involves starts, stops, delays and do-overs. Success the first time requires an experienced team of development specialists who can provide a clear and proven roadmap. Staying on schedule requires the perfect mix of technical knowledge, practical business experience and broad regulatory compliance understanding – all supported by a culture of precise execution.

The drug and medical device development process often involves starts, stops, delays and do-overs. Success the first time requires an experienced team of development specialists who can provide a clear and proven roadmap. Staying on schedule requires the perfect mix of technical knowledge, practical business experience and broad regulatory compliance understanding – all supported by a culture of precise execution.

How We Can Help

Regulatory

Regulatory

First-time success relies on the alignment of stakeholder goals – and a plan to manage those expectations – early in the development process. We facilitate successful interactions with health authorities and regulatory bodies to ensure productive outcomes.

Compliance

Compliance

We build tailored Quality Management Systems that align with development activities to minimize compliance risks. We understand the interconnected set of processes and associated dependencies which make up product development. As a result, the QMS works as designed right out of the gate.

Facilities & Capital Projects

Facilities & Capital Projects

When designing facilities structure and function, we integrate the requirements of business performance, development, and marketing strategies to ensure each facility operates at nameplate capacity on turnover.

Product & Process Development

Product & Process Development

Pharmatech’s proven methodologies ensure that your process is robust, consistent, and reliable – first time, every time. We back it up with scientific and technical know-how to ensure a robust and defensible CMC program for your product.

Modern Quality Development

Modern Quality Development

Modern Quality Development

Modern Quality Development

Modern quality approaches incorporate the interrelationship between the product development lifecycle, technical quality assurance, supply chain, and commercial capability to ensure safety and efficacy of the products that you make as well as the regulatory and quality compliance of your organization.

Modern quality approaches incorporate the interrelationship between the product development lifecycle, technical quality assurance, supply chain, and commercial capability to ensure safety and efficacy of the products that you make as well as the regulatory and quality compliance of your organization.

How We Can Help

Regulatory

Regulatory

We offer strategic guidance to help build a Quality Management System focused on efficient processes that support regulatory activities, updates, and filings.

Compliance

Compliance

A well designed Quality Management System ensures the safety and efficacy of your product as it moves through the characterization and commercial readiness process. The quality sensibility and processes are built around the scientific considerations of your product.

Facilities & Capital Projects

Facilities & Capital Projects

Using risk-based tools, timelines are condensed to make the most of your budget and minimize compliance risks. Our agile validation services are designed to evolve as regulatory, scientific, or business conditions change.

Product & Process Development

Product & Process Development

From innovation to regulatory process completion, we leverage proven methodologies that support the complex needs of a modern QMS to deliver a winning strategy.

Contact Us

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Let’s Get Started

Our unique approach can help your company navigate the complexities of launching a drug, biologic or medical device into multiple markets. The first step? Connecting. Simply fill out our form and a representative will follow-up shortly.

1.877.787.0177

22320 Foothill Blvd. Suite 330, Hayward CA 94541